Late-life DepressionCBTlateNCT03735576
Cognitive Behavioural Therapy for the Treatment of Late Life Depression
A study testing Psychotherapy, Questionnaires and Magnetic Resonance Imaging in people with Late-life Depression and Major Depressive Disorder, run by University of Cologne at 7 sites in Germany.
Trial summary
This study addresses the unmet medical problem of insufficient treatment of late life depression (LLD). Compared with depression in early adulthood, treatment options of LLD are limited. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Late-life Depression, Major Depressive Disorder, Major Depressive Episode
- What is being tested?
- Psychotherapy, Questionnaires and Magnetic Resonance Imaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 7 sitesGermany
- Study dates
- 1 Oct 2017to 11 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- out-patient status
- male or female, age ≥ 60 years
- ability to provide informed consent and written informed consent signed
- DSM-5 diagnosis of a Major Depressive Disorder/MDD (depressive episode at least moderate to severe)
- score of at least 10 on the Geriatric Depression Scale (GDS)
- score of at least 10 on the Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)
Show all 9Show fewer
- score of at least 25 in the Mini-Mental-Status-Test (MMST)
- no or stable (≥ 6 weeks) antidepressive pharmacological treatment at baseline (medication will be kept stable at least throughout the 8 weeks of treatment).
- sufficient German language skills
Who cannot join
- Bipolar depression
- Schizophrenia or other psychotic disorders
- Substance abuse or dependency
- Dementia
- Acute suicidality
- Anxiety disorder as stand-alone diagnosis (e.g. generalized anxiety disorder, panic disorder, social phobia)
Show all 12Show fewer
- Obsessive-compulsive disorder (OCD) as stand-alone diagnosis
- Participation in any another clinical trial parallel to this trial
- Additional psychological/psychotherapeutic treatment throughout the 8-week treatment period
- Regular use with scheduled daily dosing of benzodiazepines (not PRN) during 8-week treatment
- Severe or instable medical condition, which clearly impacts on depression or on the ability to participate in the trial
- Brain disease with severe functional impairment that impacts the ability to participate in the trial (e.g. aphasia, Parkinson's disease)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Charité Berlin
Berlin
University of Bonn
Bonn
University of Cologne
Cologne
University of Freiburg
Freiburg im Breisgau
University of Leipzig
Leipzig
ZI Mannheim
Mannheim
University of Tuebingen
Tübingen
About this study
Official title: Cognitive Behavioural Therapy for the Treatment of Late Life Depression - a Multicentre, Randomized, Observer- Blinded, Controlled Trial (CBTlate)
This study addresses the unmet medical problem of insufficient treatment of late life depression (LLD). Compared with depression in early adulthood, treatment options of LLD are limited. This trial is the first confirmatory multicentre study to test the efficacy of an LLD-adapted cognitive behavioural therapy (CBT) program. It will test the hypothesis, that LLD-specific cognitive behavioural therapy (CBT) is superior to unspecific supportive intervention (SUI) with regard to reducing symptoms of depression over the course of 6 months. Secondary goals are to test the efficacy of LLD-CBT in comparison with SUI on patient reported outcome in major depressive disorders (PRO-MDD), anxiety, cognition, quality of life, overall health status, sleep and global clinical impression.
- Conditions
- Late-life Depression, Major Depressive Disorder, Major Depressive Episode, Major Depressive Disorder, Recurrent
- Being tested
- Psychotherapy, Questionnaires, Magnetic Resonance Imaging, Blood analysis
- Keywords
- Late-life depression, Psychotherapy, Major depression, Randomized controlled trial, Treatment
- Medical subject headings
- Depressive Disorder, Major, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
15-session individually-delivered CBT specific for LLD in comparison with a supportive unspecific intervention (SUI) of the same quantity
QuestionnairesDiagnostic test
There will be a total of four assessments (see primary \& secondary endpoints). The first visit of the study will be a screening and baseline (T0) visit. After the baseline assessment, the subjects will be randomized to either of the two treatment arms. Within one week, the first of the successive bi-weekly 50-minute individual face-to-face treatment sessions will be performed by a study therapist. After 7 therapy sessions, the primary and secondary outcomes will be obtained in week 5 (T1) by the blinded rater. This will be followed by the treatment sessions 8 to 15 which will be carried out by the therapist. End-of-treatment primary and secondary outcomes will be obtained in week 10 (T2). The final follow-up assessment (T3) will be performed 6 months after randomization by the blinded rater.
Magnetic Resonance ImagingOther
Underlying mechanisms are examined using neuroimaging. MRI data are acquired at four scanning sites and will be performed at baseline, end-of-treatment and follow-up to obtain a high-resolution structural T1-weighted image, a T2-weighted FLAIR image, a resting state fMRI, and diffusion tensor imaging (DTI) of the subjects' brain.
Blood analysisOther
Blood sampling will be acquired in order to investigate the underlying mechanisms in LLD and the specific effects of psychotherapy. Blood samples are acquired at five sites at baseline (T0), T1, T2 and T3 for genetic and epigenetic analyses, measurement of Amyloid-β, Neurofilament light chain (NFL), Peripheral Blood Mononuclear Cells (PBMCs), Metabolomics, Proteomics and miRNA analyses.
| Study group | Role | What they receive |
|---|---|---|
| LLD-adapted cognitive behavioural therapy (CBT) | Experimental | manualized 15-session individually-delivered cognitive behavioural therapy (CBT) specific for late life depression (LLD) Receives: Behavioral: Psychotherapy; Diagnostic Test: Questionnaires; Other: Magnetic Resonance Imaging; Other: Blood analysis |
| supportive unspecific intervention (SUI) | Active comparator | manualized 15-session individually-delivered supportive unspecific intervention (SUI) Receives: Behavioral: Psychotherapy; Diagnostic Test: Questionnaires; Other: Magnetic Resonance Imaging; Other: Blood analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Geriatric Depression Scale (GDS) Score
The primary end point is the change in depression severity from baseline to week 10 measured by the 30-item Geriatric Depression Scale (GDS). It is a self-rating scale including 30 Items in a yes/no format and a total score range from 0 to 30. Higher values represent worse outcome.
Measured: 10 weeks
Secondary outcomes (25)
Change of Geriatric Depression Scale (GDS) Score
A secondary outcome measure is the change in depression severity from baseline to week 5 measured by the 30-item Geriatric Depression Scale (GDS). It is a self-rating scale including 30 Items in a yes/no format and a total score range from 0 to 30. Higher values represent worse outcome.
Measured: 5 weeks
Change of Geriatric Depression Scale (GDS) Score
A secondary outcome measure is the change in depression severity from baseline to month 6 measured by the 30-item Geriatric Depression Scale (GDS). It is a self-rating scale including 30 Items in a yes/no format and a total score range from 0 to 30. Higher values represent worse outcome.
Measured: 6 months
Change of Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C)
A secondary outcome measure is the change in depression severity from baseline to week 5 measured by the 16-item Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C). It is a clinician-rated scale including 16 Items and a total score range from 0 to 27. Higher values represent worse outcome.
Measured: 5 weeks
Change of Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C)
A secondary outcome measure is the change in depression severity from baseline to week 10 measured by the 16-item Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C). It is a clinician-rated scale including 16 Items and a total score range from 0 to 27. Higher values represent worse outcome.
Measured: 10 weeks
Change of Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C)
A secondary outcome measure is the change in depression severity from baseline to month 6 measured by the 16-item Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C). It is a clinician-rated scale including 16 Items and a total score range from 0 to 27. Higher values represent worse outcome.
Measured: 6 months
Change of Patient Reported Outcome for Major Depressive Disorder (PRO-MDD) Score
A secondary outcome measure is the change in depression severity from baseline to week 10 measured by the 35-item Patient Reported Outcome for Major Depressive Disorder (PRO-MDD) Score. It is a self-rating scale including 35 Items on an11-point numeric rating scale. Higher values represent worse outcome.
Measured: 10 weeks
Change of Patient Reported Outcome for Major Depressive Disorder (PRO-MDD) Score
A secondary outcome measure is the change in depression severity from baseline to month 6 measured by the 35-item Patient Reported Outcome for Major Depressive Disorder (PRO-MDD) Score. It is a self-rating scale including 35 Items on an11-point numeric rating scale. Higher values represent worse outcome.
Measured: 6 months
Longitudinal Interval Follow-up Evaluation (LIFE)
A secondary outcome measure is the longitudinal evaluation of depressive symptoms by the Longitudinal Interval Follow-up Evaluation Interview (LIFE) at month 6.
Measured: 6 months
Change of Insomnia Severity Index (ISI) Score
A secondary outcome measure is the change in insomnia severity from baseline to week 10 measured by the 7-item Insomnia Severity Index (ISI). It is a self-rating scale including 7 Items rated on a scale from 0 to 4 from less to more severe. The total score ranges from 0 to 28. Higher values represent worse outcome.
Measured: 10 weeks
Change of Insomnia Severity Index (ISI) Score
A secondary outcome measure is the change in insomnia severity from baseline to month 6 measured by the 7-item Insomnia Severity Index (ISI). It is a self-rating scale including 7 Items rated on a scale from 0 to 4 from less to more severe. The total score ranges from 0 to 28. Higher values represent worse outcome.
Measured: 6 months
Change of Epworth Sleepiness Scale (ESS) Score
A secondary outcome measure is the change in sleepiness from baseline to week 10 measured by the 8-item Epworth Sleepiness Scale (ESS). It is a self-rating scale including 8 Items rated on a 4-point Likert scale. The total score ranges from 0 to 24. Higher values represent worse outcome.
Measured: 10 weeks
Change of Epworth Sleepiness Scale (ESS) Score
A secondary outcome measure is the change in sleepiness from baseline to month 6 measured by the 8-item Epworth Sleepiness Scale (ESS). It is a self-rating scale including 8 Items rated on a 4-point Likert scale. The total score ranges from 0 to 24. Higher values represent worse outcome.
Measured: 6 months
Change of REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)Score
A secondary outcome measure is the change in REM sleep behavior from baseline to week 10 measured by the 10-item REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ). It is a self-rating scale including 10 Items in a yes/no format. The total score ranges from 0 to 13. Higher values represent worse outcome.
Measured: 10 weeks
Change of REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)Score
A secondary outcome measure is the change in REM sleep behavior from baseline to month 6 measured by the 10-item REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ). It is a self-rating scale including 10 Items in a yes/no format. The total score ranges from 0 to 13. Higher values represent worse outcome.
Measured: 6 months
Change of Geriatric Anxiety Inventory (GAI) Score
A secondary outcome measure is the change in anxiety symptoms from baseline to week 10 measured by the 20-item Geriatric Anxiety Inventory (GAI). It is a self-rating scale including 20 Items in a agree/disagree format and a total score range from 0 to 20. The cut-off score of 9 classifies the presence of clinically significant anxiety. Higher values represent worse outcome.
Measured: 10 weeks
Change of Geriatric Anxiety Inventory (GAI) Score
A secondary outcome measure is the change in anxiety symptoms from baseline to month 6 measured by the 20-item Geriatric Anxiety Inventory (GAI). It is a self-rating scale including 20 Items in a agree/disagree format and a total score range from 0 to 20. The cut-off score of 9 classifies the presence of clinically significant anxiety. Higher values represent worse outcome.
Measured: 6 months
Change in Quality of Life (WHOQOL)
A secondary outcome measure is the change in quality of life from baseline to week 10 measured by the 24-item WHOQOL-OLD and 26-item WHOQOL-BREF.
Measured: 10 weeks
Change in Quality of Life (WHOQOL)
A secondary outcome measure is the change in quality of life from baseline to month 6 measured by the 24-item WHOQOL-OLD and 26-item WHOQOL-BREF.
Measured: 6 months
Change in Short Form Health Survey (SF-36)
A secondary outcome measure is the change in overall health status from baseline to week 10 measured by the 36-item Short Form Health Survey (SF-36).
Measured: 10 weeks
Change in Short Form Health Survey (SF-36)
A secondary outcome measure is the change in overall health status from baseline to month 6 measured by the 36-item Short Form Health Survey (SF-36).
Measured: 6 months
Change in Subjective Cognitive Functioning
A secondary outcome measure is the change in subjective cognitive functioning from baseline to month 6 measured by the semi-structured Subjective Cognitive Decline interview.
Measured: 6 months
Change in cognitive function (CERAD-Plus)
A secondary outcome measure is the change in cognitive function from baseline to month 6 measured by the Consortium to Establish a Registry for Alzheimer's Disease (CERAD-Plus) neuropsychological test battery.
Measured: 6 months
Change in executive function (NAB maze test)
A secondary outcome measure is the change in executive function from baseline to month 6 measured by the Neuropsychological Assessment Battery (NAB) maze subtest.
Measured: 6 months
Childhood Trauma Questionnaire (CTQ)
Assessment of the severity of five categories of childhood trauma(emotional/physical/sexual abuse and emotional/physical neglect) at baseline
Measured: baseline
Big Five-Inventory 10 Item Short Version (BFI-10)
10-item scale measuring the personality traits Extraversion, Agreeableness, Conscientiousness, Emotional Stability, and Openness to assess the influence of personality traits on treatment outcome at baseline. The items are rated on a five-step scale from 1 "disagree strongly" to 5 "agree strongly". The scale consists of 2 BFI items for each Big Five Dimension.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start1 Oct 2017
- Primary completion11 May 2021
- Study completion11 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Late-life DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, multi-center, single blind (observer-blinded), active-controlled, parallel group trial (therapeutic confirmatory) in 248 patients with late-life depression of both genders at 7 trial sites in Germany. The intervention includes 8 weeks of manual-based, individual, 15-session, twice weekly, outpatient treatment for patients with late life depression in each arm of the trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Jessen, University of Cologne
- Investigators
- Frank Jessen, Prof.Dr., Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735576
- Sponsor's protocol ID
- 01KG1716
- Acronym
- CBTlate
- Status last verified
- May 2022
- First submitted
- 24 Oct 2018
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bewernick B, Buschmann J, Heser K, Kleineidam L, Domschke K, Elsaesser M, Zehender N, Luppa M, Hellmich M, Peters O, Froelich L, Riedel-Heller S, Schramm E, Hautzinger M, Jessen F, Dafsari FS, Wagner M. The effect of cognition and age on the efficacy of psychotherapy in late-life depression. J Affect Disord. 2025 Dec 15;391:119881. doi: 10.1016/j.jad.2025.119881. Epub 2025 Jul 14.
PubMed 40669702Muller J, Elsaesser M, Berger R, Muller W, Hellmich M, Zehender N, Riedel-Heller S, Bewernick BH, Wagner M, Frolich L, Peters O, Domschke K, Jessen F, Hautzinger M, Dafsari FS, Schramm E. The Impact of Loneliness on Late-Life Depression and Anxiety During the COVID-19 Pandemic. Am J Geriatr Psychiatry. 2025 Jul;33(7):717-729. doi: 10.1016/j.jagp.2025.01.003. Epub 2025 Jan 21.
PubMed 39884877Dafsari FS, Bewernick B, Bohringer S, Domschke K, Elsaesser M, Lobner M, Luppa M, Schmitt S, Wingenfeld K, Wolf E, Zehender N, Hellmich M, Muller W, Wagner M, Peters O, Frolich L, Riedel-Heller S, Schramm E, Hautzinger M, Jessen F. Perceived Physical Health and Cognitive Behavioral Therapy vs Supportive Psychotherapy Outcomes in Adults With Late-Life Depression: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e245841. doi: 10.1001/jamanetworkopen.2024.5841.
PubMed 38619842Dafsari FS, Bewernick B, Biewer M, Christ H, Domschke K, Froelich L, Hellmich M, Luppa M, Peters O, Ramirez A, Riedel-Heller S, Schramm E, Vry MS, Wagner M, Hautzinger M, Jessen F. Cognitive behavioural therapy for the treatment of late life depression: study protocol of a multicentre, randomized, observer-blinded, controlled trial (CBTlate). BMC Psychiatry. 2019 Dec 27;19(1):423. doi: 10.1186/s12888-019-2412-0.
PubMed 31881995
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioural Therapy for the Treatment of Late Life Depression - a Multicentre, Randomized, Observer- Blinded, Controlled Trial (CBTlate)
- ClinicalTrials.gov ID
- NCT03735576
- Acronym / sponsor ID
- CBTlate / 01KG1716
- Conditions
- Late-life Depression, Major Depressive Disorder, Major Depressive Episode, Major Depressive Disorder, Recurrent
- Keywords
- Late-life depression, Psychotherapy, Major depression, Randomized controlled trial, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 11 May 2021 (actual)
- Study completion
- 11 May 2021 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study addresses the unmet medical problem of insufficient treatment of late life depression (LLD). Compared with depression in early adulthood, treatment options of LLD are limited. This trial is the first confirmatory multicentre study to test the efficacy of an LLD-adapted cognitive behavioural therapy (CBT) program. It will test the hypothesis, that LLD-specific cognitive behavioural therapy (CBT) is superior to unspecific supportive intervention (SUI) with regard to reducing symptoms of depression over the course of 6 months. Secondary goals are to test the efficacy of LLD-CBT in comparison with SUI on patient reported outcome in major depressive disorders (PRO-MDD), anxiety, cognition, quality of life, overall health status, sleep and global clinical impression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, multi-center, single blind (observer-blinded), active-controlled, parallel group trial (therapeutic confirmatory) in 248 patients with late-life depression of both genders at 7 trial sites in Germany. The intervention includes 8 weeks of manual-based, individual, 15-session, twice weekly, outpatient treatment for patients with late life depression in each arm of the trial.
| Arm | Type | Receives |
|---|---|---|
| LLD-adapted cognitive behavioural therapy (CBT) | Experimental | Behavioral: Psychotherapy, Diagnostic Test: Questionnaires, Other: Magnetic Resonance Imaging, Other: Blood analysismanualized 15-session individually-delivered cognitive behavioural therapy (CBT) specific for late life depression (LLD) |
| supportive unspecific intervention (SUI) | Active comparator | Behavioral: Psychotherapy, Diagnostic Test: Questionnaires, Other: Magnetic Resonance Imaging, Other: Blood analysismanualized 15-session individually-delivered supportive unspecific intervention (SUI) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- out-patient status
- male or female, age ≥ 60 years
- ability to provide informed consent and written informed consent signed
- DSM-5 diagnosis of a Major Depressive Disorder/MDD (depressive episode at least moderate to severe)
- score of at least 10 on the Geriatric Depression Scale (GDS)
Key exclusion criteria (12 listed)
- Bipolar depression
- Schizophrenia or other psychotic disorders
- Substance abuse or dependency
- Dementia
- Acute suicidality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychotherapy15-session individually-delivered CBT specific for LLD in comparison with a supportive unspecific intervention (SUI) of the same quantity | Behavioural | LLD-adapted cognitive behavioural therapy (CBT), supportive unspecific intervention (SUI) |
| QuestionnairesThere will be a total of four assessments (see primary \& secondary endpoints). The first visit of the study will be a screening and baseline (T0) visit. After the baseline assessment, the subjects will be randomized to either of the two treatment arms. Within one week, the first of the successive bi-weekly 50-minute individual face-to-face treatment sessions will be performed by a study therapist. After 7 therapy sessions, the primary and secondary outcomes will be obtained in week 5 (T1) by the blinded rater. This will be followed by the treatment sessions 8 to 15 which will be carried out by the therapist. End-of-treatment primary and secondary outcomes will be obtained in week 10 (T2). The final follow-up assessment (T3) will be performed 6 months after randomization by the blinded rater. | Diagnostic test | LLD-adapted cognitive behavioural therapy (CBT), supportive unspecific intervention (SUI) |
| Magnetic Resonance ImagingUnderlying mechanisms are examined using neuroimaging. MRI data are acquired at four scanning sites and will be performed at baseline, end-of-treatment and follow-up to obtain a high-resolution structural T1-weighted image, a T2-weighted FLAIR image, a resting state fMRI, and diffusion tensor imaging (DTI) of the subjects' brain. | Other | LLD-adapted cognitive behavioural therapy (CBT), supportive unspecific intervention (SUI) |
| Blood analysisBlood sampling will be acquired in order to investigate the underlying mechanisms in LLD and the specific effects of psychotherapy. Blood samples are acquired at five sites at baseline (T0), T1, T2 and T3 for genetic and epigenetic analyses, measurement of Amyloid-β, Neurofilament light chain (NFL), Peripheral Blood Mononuclear Cells (PBMCs), Metabolomics, Proteomics and miRNA analyses. | Other | LLD-adapted cognitive behavioural therapy (CBT), supportive unspecific intervention (SUI) |
Primary outcome
Change of Geriatric Depression Scale (GDS) Score
Time frame: 10 weeks
The primary end point is the change in depression severity from baseline to week 10 measured by the 30-item Geriatric Depression Scale (GDS). It is a self-rating scale including 30 Items in a yes/no format and a total score range from 0 to 30. Higher values represent worse outcome.
25 secondary outcomes
Change of Geriatric Depression Scale (GDS) Score
Time frame: 5 weeks
Change of Geriatric Depression Scale (GDS) Score
Time frame: 6 months
Change of Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C)
Time frame: 5 weeks
Change of Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C)
Time frame: 10 weeks
Change of Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C)
Time frame: 6 months
Change of Patient Reported Outcome for Major Depressive Disorder (PRO-MDD) Score
Time frame: 10 weeks
Change of Patient Reported Outcome for Major Depressive Disorder (PRO-MDD) Score
Time frame: 6 months
Longitudinal Interval Follow-up Evaluation (LIFE)
Time frame: 6 months
Change of Insomnia Severity Index (ISI) Score
Time frame: 10 weeks
Change of Insomnia Severity Index (ISI) Score
Time frame: 6 months
Change of Epworth Sleepiness Scale (ESS) Score
Time frame: 10 weeks
Change of Epworth Sleepiness Scale (ESS) Score
Time frame: 6 months
Change of REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)Score
Time frame: 10 weeks
Change of REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)Score
Time frame: 6 months
Change of Geriatric Anxiety Inventory (GAI) Score
Time frame: 10 weeks
Change of Geriatric Anxiety Inventory (GAI) Score
Time frame: 6 months
Change in Quality of Life (WHOQOL)
Time frame: 10 weeks
Change in Quality of Life (WHOQOL)
Time frame: 6 months
Change in Short Form Health Survey (SF-36)
Time frame: 10 weeks
Change in Short Form Health Survey (SF-36)
Time frame: 6 months
Change in Subjective Cognitive Functioning
Time frame: 6 months
Change in cognitive function (CERAD-Plus)
Time frame: 6 months
Change in executive function (NAB maze test)
Time frame: 6 months
Childhood Trauma Questionnaire (CTQ)
Time frame: baseline
Big Five-Inventory 10 Item Short Version (BFI-10)
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Derived from this study: PubMed 40669702Bewernick B, Buschmann J, Heser K, Kleineidam L, Domschke K, Elsaesser M, Zehender N, Luppa M, Hellmich M, Peters O, Froelich L, Riedel-Heller S, Schramm E, Hautzinger M, Jessen F, Dafsari FS, Wagner M. The effect of cognition and age on the efficacy of psychotherapy in late-life depression. J Affect Disord. 2025 Dec 15;391:119881. doi: 10.1016/j.jad.2025.119881. Epub 2025 Jul 14.
- Derived from this study: PubMed 39884877Muller J, Elsaesser M, Berger R, Muller W, Hellmich M, Zehender N, Riedel-Heller S, Bewernick BH, Wagner M, Frolich L, Peters O, Domschke K, Jessen F, Hautzinger M, Dafsari FS, Schramm E. The Impact of Loneliness on Late-Life Depression and Anxiety During the COVID-19 Pandemic. Am J Geriatr Psychiatry. 2025 Jul;33(7):717-729. doi: 10.1016/j.jagp.2025.01.003. Epub 2025 Jan 21.
- Derived from this study: PubMed 38619842Dafsari FS, Bewernick B, Bohringer S, Domschke K, Elsaesser M, Lobner M, Luppa M, Schmitt S, Wingenfeld K, Wolf E, Zehender N, Hellmich M, Muller W, Wagner M, Peters O, Frolich L, Riedel-Heller S, Schramm E, Hautzinger M, Jessen F. Perceived Physical Health and Cognitive Behavioral Therapy vs Supportive Psychotherapy Outcomes in Adults With Late-Life Depression: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e245841. doi: 10.1001/jamanetworkopen.2024.5841.
- Derived from this study: PubMed 31881995Dafsari FS, Bewernick B, Biewer M, Christ H, Domschke K, Froelich L, Hellmich M, Luppa M, Peters O, Ramirez A, Riedel-Heller S, Schramm E, Vry MS, Wagner M, Hautzinger M, Jessen F. Cognitive behavioural therapy for the treatment of late life depression: study protocol of a multicentre, randomized, observer-blinded, controlled trial (CBTlate). BMC Psychiatry. 2019 Dec 27;19(1):423. doi: 10.1186/s12888-019-2412-0.
Related trials for Late-life Depression
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
Recruiting
Risk and Resilience to Suicide Following Late-Life Spousal Bereavement
Suicide, Bereavement
Recruiting
Accelerated vs. Conventional Theta Burst Stimulation for Late-life Depression
Late Life Depression (LLD), Depression - Major Depressive Disorder
Not yet recruitingPhase 2
The BAARD Study : Evaluating a Computerized Approach to Treatment Selection in Older Adults With Treatment Resistant Depression.
Late Life Treatment Resistant Depression, Depression - Major Depressive Disorder
Active, not recruiting
Individualized Targeting and Neuromodulation of Late-Life Depression
Major Depressive Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Jessen, Prof.Dr. principal investigator
University of Cologne
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy, Questionnaires and Magnetic Resonance Imaging in people with Late-life Depression and Major Depressive Disorder, run by University of Cologne at 7 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Geriatric Depression Scale (GDS) Score (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03735576, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.